Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LIFEPAK 20 external defibrillator/monitor

FDA Recall Z-1502-06 · Posted 2006-09-13

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2006-08-30
Date Terminated2011-03-25
Product Quantity2,831 worldwide

Reason for Recall

Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.

Firm Action

On August 30, 2006 the firm issued a letter dated August 2006 and titled MEDICAL DEVICE CORRECTION. The letter advises of the issue, explains how to resume power if power is shut down without warning, and advsies that a service representative will contact the consignee to make arrangements to install new software. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall.

Root Cause

Other

Distribution Pattern

Units were distributed worldwide to hospitals and medical centers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERMedtronic Physio-Control Corp. · 2002-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑